Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA, EU To Redouble Inspection Of Asian Pharmaceutical Supply Chains

Executive Summary

Mutual recognition agreement enables US and European authorities to redirect inspectional resources to China and India. The result could be more warning letters and other actions unless global companies strengthen oversight of ingredient suppliers and contract manufacturers in Asia, current and former FDA officials say.

You may also be interested in...



US FDA's Inspection Decisions To Be Swayed By Facility "History" With Foreign Regulators

Leveraging foreign surveillance inspections could help FDA ensure more sites are inspected more often.

Leader Of US FDA's EU Mutual Recognition Effort Departs For Industry

Dara Corrigan will become Fresenius-Kabi’s VP for global affairs and policy.

FDA Tip-Toes In China To Push Data Integrity, Harmonization

US FDA warning letters to Chinese firms may be on the increase, but ties with the Chinese regulator appear to be growing. US FDA showcases how to get more done in fast-changing China via aligning with China FDA's aspiration for quality and international harmonization.

Related Content

Topics

UsernamePublicRestriction

Register

PS120739

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel